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Completed

NCT Number: NCT03804684

visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry

To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.

Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.

The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 21 to 80 years
  • Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
  • mild glaucoma subjects with less than -6 mean deviation
  • moderate glaucoma subjects with -6 to -12 mean deviation

Exclusion criteria

  • spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
  • Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
  • Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
  • SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
  • Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
  • History of systemic condition known to affect visual function
  • History of medication known to affect visual function

Treatment and study plan

Standard Automatic Perimetry Humphrey Field Analyzer

Diagnostic Test

Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.

Other names: SAP HFA

VisuALL Field Analyzer

Diagnostic Test

visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.

Other names: vFA

Primary outcomes

  1. Mean Retinal Sensitivity From Two Machines

    Time frame: three hours

    Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.

  2. Global Correlation (Agreement Between Two Machines in the Overall Visual Field)

    Time frame: three hours

    Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.

Secondary outcomes

  1. Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)

    Time frame: three hours

    Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.

  2. Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field

    Time frame: three hours

    Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Olleyes, Inc.

Registry information

Official study title

How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2019
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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